MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S850C
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 50cc 8.0fr rediguard intra-aortic balloon catheter.Upon return, the teflon sheath was noted on the iabc.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Kinks to the iabc central lumen was noted at approximately 28.7cm, 32.5cm and 33.6cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0064in-0.0078in and was within specification.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute and then 30 seconds five separate times.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested and no leaks were detected.Full inflation was achieved.The device passed the leak test.The iabc was connected to an iabp using a lab inventory 30cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.The iabc was pumped for a minimum of 15 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 28.7cm, 32.5cm and 33.6cm from the iabc distal tip, which are the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.No blood or debris was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint for "helium loss alarms" is confirmed.Multiple kinks to the central lumen were noted during the visual inspection of the returned iab catheter, and resistance was noted at the location of the kinks upon loading a guidewire into the iabc central lumen.The kinked central lumen can result in the reported alarms.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the kinked central lumen.The root cause of the kink is undetermined, but a potential cause is customer handling.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "ccl placed iab and started receiving helium loss alarms, decided to remove the catheter.Upon removal [the user] observed 2 kinks in the sheath.They did not place a new iab.No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: ARROW REDIGUARD IAB: 8FR 50CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 20216717
• Report Number: 3010532612-2024-00766
• Device Sequence Number: 15404042
• Product Code: DSP
• UDI-Device Identifier: 10801902144208
• UDI-Public: (01)10801902144208(11)240426(17)260331(10)18F24D0106(21)
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: IAB-S850C
• Device Lot Number: 18F24D0106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown